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A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products

NCT04027855 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-01-10

No results posted yet for this study

Summary

The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products.

Conditions

  • Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis

Interventions

PROCEDURE

collection of peripheral blood mononuclear cells from healthy volunteers

1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled. 2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.

Sponsors & Collaborators

  • Nanjing Legend Biotechnology Co.,Ltd.

    collaborator UNKNOWN

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu, PhD& MD · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2021-12-09
Completion
2021-12-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027855 on ClinicalTrials.gov